Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer

Cancer Clinical Trial

— PALANGI-0601  

Official title:

A Phase II Randomized Study to Assess the Benefit of a Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00420563
• Other study ID #: PAL-ANGI 0601
• Status: Completed
• Phase: Phase 2
• First received: January 9, 2007
• Last updated: July 20, 2012
• Start date: September 2006
• Est. completion date: July 2009

Study information

• Verified date: July 2012
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The scope of the trial is to assess the free progression rate at 2 months for each group of patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: July 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > or = 18

• PS-WHO < or = 1

• Histologically proven cancer

• No other therapeutic proposal

• Treatment can be orally taken

• Radiologic proof of evolutive character of the disease

• Effective contraception

Exclusion Criteria:

• Hypercalcemia ( Ca > 2.65 mmol/l)

• Breast cancer

• Thrombosis or pulmonary embolism

• Dysphagia, malabsorption

• Polynuclear neutrophil leukocytes < 1000/mm3

• Treatment with Tegretol

• Active and uncontrolled infection

• Evolutive psychiatric disease

• Pregnant or lactating woman

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• CYCLOPHOSPHAMIDE
50 mg x 2 /day , per os, nonstop until disease progression or toxicity or patient decision
• MEGESTROL
320 mg/day, per os, 2 pills of 160 mg one time, nonstop until disease progression or toxicity or patient decision

Locations

Country	Name	City	State
France	Centre Hospitalier Regional - Dermatology	Lille
France	Centre Hospitalier Regional - Oncology	Lille
France	Centre Oscar Lambret	Lille
France	Hopital Saint Vincent	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival rate at 2 months		2 months	No
Secondary	Progression free survival rate and objective response (RECIST) at 2, 4 and 6 months		After 2, 4 and 6 months of treatment	No
Secondary	Toxicity according to NCI scale v3.0		During study treatment	Yes
Secondary	Biological markers		the 2 first months of treatment	No
Secondary	Overall survival		Until death of the patient or until study analysis	No
Secondary	Median time between the beginning of treatment and hospitalization due to progression or toxicity		time of the study	No